By MARIA CHENG
AP Medical Writer
LONDON (AP) - A leading British
medical journal is asking the drug maker Roche to release all its data
on Tamiflu, claiming there is no evidence the drug can actually stop the
flu.
The drug has been stockpiled by
dozens of governments worldwide in case of a global flu outbreak and was
widely used during the 2009 swine flu pandemic.
On Monday, one of the researchers linked to the BMJ journal called for European governments to sue Roche.
"I suggest we boycott Roche's
products until they publish missing Tamiflu data," wrote Peter Gotzsche,
leader of the Nordic Cochrane Centre in Copenhagen. He said governments
should take legal action against Roche to get the money back that was
"needlessly" spent on stockpiling Tamiflu.
Last year, Tamiflu was included
in a list of "essential medicines" by the World Health Organization, a
list that often prompts governments or donor agencies to buy the drug.
Tamiflu is used to treat both
seasonal flu and new flu viruses like bird flu or swine flu. WHO
spokesman Gregory Hartl said the agency had enough proof to warrant its
use for unusual influenza viruses, like bird flu.
"We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.
In the U.S., the Centers for
Disease Control and Prevention recommends Tamiflu as one of two
medications for treating regular flu. The other is GlaxoSmithKline's
Relenza. The CDC says such antivirals can shorten the duration of
symptoms and reduce the risk of complications and hospitalization.
In 2009, the BMJ and researchers
at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data
available. At the time, Cochrane Centre scientists were commissioned by
Britain to evaluate flu drugs. They found no proof that Tamiflu reduced
the number of complications in people with influenza.
"Despite a public promise to
release (internal company reports) for each (Tamiflu) trial...Roche has
stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.
In a statement, Roche said it
had complied with all legal requirements on publishing data and provided
Gotzsche and his colleagues with 3,200 pages of information to answer
their questions.
"Roche has made full clinical
study data ... available to national health authorities according to
their various requirements, so they can conduct their own analyses," the
company said.
Roche says it doesn't usually
release patient-level data available due to legal or confidentiality
constraints. It said it did not provide the requested data to the
scientists because they refused to sign a confidentiality agreement.
Roche is also being investigated
by the European Medicines Agency for not properly reporting side
effects, including possible deaths, for 19 drugs including Tamiflu that
were used in about 80,000 patients in the U.S.
Source : http://www.wthr.com/story/20069882/british-medical-journal-slams-roche-on-tamiflu